ADC-1013 First-in-Human Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-03-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether ADC-1013 (an agonistic human monoclonal IgG1 anti-CD40 antibody) is safe and tolerable when administered intratumorally (as repeated injections directly into the tumor tissue) or intravenously (as repeated doses directly into a vein) in patients with advanced solid tumors.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 in Participants With Selected Advanced Solid Tumors

NCT04972981

Advanced Solid Tumors

COMPLETED PHASE1

Phase 1 Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of ATOR-1017

NCT04144842

Solid Tumor Neoplasms

COMPLETED PHASE1

ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers

NCT07238075

Advanced Malignancy Advanced Solid Cancers Metastatic Solid Tumors

NOT_YET_RECRUITING PHASE1

Safety, Tolerability, Pharmacokinetics, and Antitumor Study of ADCT-601 to Treat Advanced Solid Tumors

NCT03700294

Advanced Solid Tumors

TERMINATED PHASE1

A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies

NCT04244552

Breast Cancer Colorectal Cancer Ovarian Cancer +13 more

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ADC-1013 intratumoral

ADC-1013 (agonistic human monoclonal IgG1 anti-CD40 antibody) administered by intratumoral injection every second week for 8 weeks. Patients that do not progress will be offered continued treatment until complete response, confirmed progressive disease, or clinical deterioration.

Group Type EXPERIMENTAL

ADC-1013

Intervention Type BIOLOGICAL

Agonistic human monoclonal IgG1 anti-CD40 antibody

ADC-1013 intravenous

ADC-1013 (agonistic human monoclonal IgG1 anti-CD40 antibody) administered by intravenous infusion every second week until complete response, confirmed progressive disease, or clinical deterioration.

Group Type EXPERIMENTAL

ADC-1013

Intervention Type BIOLOGICAL

Agonistic human monoclonal IgG1 anti-CD40 antibody

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ADC-1013

Agonistic human monoclonal IgG1 anti-CD40 antibody

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of advanced solid tumor disease
* Performance status of 0-1 on the ECOG scale
* Life expectancy of at least 3 months

Exclusion Criteria

* Organ transplant recipient
* Autoimmune disorder
* Other malignancy (except localized prostate cancer, adequately treated basal skin cancer or carcinoma in-situ of the cervix)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No